Q3 2020 MacroGenics Inc Earnings Call

We will begin to Michael Jackson thousand and 23rd quarter call corporate progress and financial results conference call in just a moment.

Operator: We will begin the MicroGenics 2020 Third Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in listen-only mode.

All participants are in listen only mode.

Operator: At this point, and we will conduct a question and answer session at the end of the call, I will turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer of MicroGenics. Sir, you may begin. What the hell's going on?

At the moment and we will conduct a question and answer session at the end of the call.

At this point I will turn the call over to Jim Curley Senior Vice President and Chief Financial Officer, Michael Jennings, Sir you may begin.

[music].

James Karrels: Thank you. Good afternoon, and welcome to MacroGenics' conference call to discuss our third quarter 2020 financial and operational results. For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at MacroGenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed. I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995. However, actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed, in the risk factors section of our annual, quarterly, and current reports filed with the S In addition, any forward-looking statements represent our views only as of today, and they should not be relied upon as representing our views as of any subsequent date.

For anyone who has not had the chance to review. These results we should a press release. This afternoon outlining today's announcement, which is available under the investors tab on our website at Macrogenics Dot com.

You May also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.

Well look to alert listeners that todays discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements as statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed.

In the risk factor section of our annual quarterly and current reports filed with the SEC.

In addition, any forward looking statements represent our views only as of today it should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future.

Operator: While we may elect to update these forward-looking statements at some point in the future, now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MacroGenics. Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key highlights from our clinical programs. But before I do so, I'll first turn the call back to Jim, who will review our financial results for the quarter.

Typically disclaim any obligation to do so even if our views change except to the extent required by applicable law and now I'd like to turn the call over to Dr., Scott King President and Chief Executive Officer of Macrogenics.

Thank you Jim I'd like to welcome everyone participating via conference call and webcast today.

This afternoon, I will provide key highlights from our clinical programs, but before I do so let me first turn the call back to Jim who will review our financial results for the quarter.

Thank you Scott This afternoon Macrogenics reported financial results for the quarter ended September 30, 2020, which highlights our financial position as well as our recent progress as.

James Karrels: Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended September 30, 2020, which highlight our financial position as well as our recent progress. As described in our release this afternoon, MacroGenics' total revenue, consisting primarily of revenue from collaborative arrangements, was $18.2 million for the quarter ended September 30, 2020, compared to $18.7 million for the quarter ended September 30, 2019. Revenue recognized during the quarter ended September 30, 2020, included a $15 million milestone from Insight. Our research and development expenses were $44.7 million for the quarter ended September 30, 2020, compared to $44.9 million for the quarter ended September 30, 2019. General and administrative expenses were $9.7 million for the quarter ended September 30, 2020, compared to $11.8 million for the quarter ended September 30, 2019. This decrease is primarily due to a reduction in external expenses, including consulting costs.

As described in our release this afternoon Macrogenics total revenue consisting primarily of revenue from collaborative arrangements was $18.2 million for the quarter ended September 32020, compared to 18.7 million for the quarter ended September 32019 revenue recognized during the quarter ended September 32020.

You did a $15 million milestone from inside.

Our research and development expenses were $44.7 million for the quarter ended September 32020, compared to $44.9 million for the quarter ended September 32019.

General and administrative expenses were $9.7 million for the quarter ended September 32020, compared to $11.8 million for the quarter ended September 32019. This decrease is primarily due to a reduction in external expenses, including consulting costs.

Macrogenics net loss was $36 million for the quarter ended September 32020, compared to a net loss of $44.6 million for the quarter ended September 32019.

James Karrels: MacroGenics' net loss was $36 million for the quarter ended September 30, 2020 compared to a net loss of $44.6 million for the quarter ended September 30, 2019. Our cash, cash equivalents, and markable securities as of September 30, 2020 were $280.7 million compared to $215.8 million as of December 31, 2019. During the quarter ended September 30, 2020, we received $75.7 million in gross proceeds from the sale of approximately 2.55 million shares of our common stock pursuant to an at-the-market or ATM offering at an average sale price per share of $29.67. With the sale of these shares, we fully exhausted the dollar amount of shares that were available for sale under the ATM.

Our cash cash equivalents and marketable securities as of September 32020 were $280.7 million compared to $215.8 million as of December 31, 2019.

During the quarter ended September 32020, we received $75.7 million in gross proceeds.

From the sale of approximately 2.55 million shares of our common stock pursuant to an aftermarket or ATM offering and an average sale price per share of $29.67.

With the sale of these shares with we fully exhausted the dollar amount of shares that were available for sale under the ATM.

As you May have seen we filed a new ones afternoon in the amount of $100 million as a matter of financial housekeeping.

James Karrels: As you may have seen, we filed a new one this afternoon in the amount of $100 million as a matter of financial housekeeping. We believe that it is prudent to have this financing vehicle in place for potential future use. Let me also point out that the $15 million milestone from Insight was received after September 30, 2020, and was therefore reflected on our balance sheet as a receivable. Finally, there is no adjustment necessary to our previously disclosed cash guidance.

We believe that it is prudent to have this financing vehicles in place for potential future use. Let me also point out that the $15 million milestone from insight was received after September 32020, and it was therefore reflected on our balance sheet as a receivable.

Finally, there was no adjustment necessary to our previously disclosed cash guidance and to remind listeners we anticipate that our cash cash equivalents and marketable securities as of September 32020, combined with anticipated and potential collaboration payments should enable us to fund our operations into 2023, assuming the company's programs.

James Karrels: And to remind listeners, we anticipate that our cash, cash equivalents, and markable securities as of September 30, 2020, combined with anticipated and potential collaboration payments, should enable us to fund our operations into 2023, assuming the company's programs and collaborations advance as currently contemplated. Now, I'll turn the call back to Scott. Thank you, Jim.

Collaborations advance as currently contemplated and now I'll turn the call back to Scott.

Thank you Jim.

We continue to be excited about the momentum we have built to date 2020 as well as the a bench we are anticipating during the remainder of the year and then to 2021 we.

We are particularly excited about the multiple registrational potentially registration, enabling studies currently underway that involves macrogenics, oh molecule or those we have coffers.

First we await the near term produces a decision by the U.S.F.D.A. regarding merger talks about in my mind her two positive metastatic breast cancer.

Scott Koenig: We continue to be excited about the momentum we have built to date in 2020, as well as the events we are anticipating during the remainder of the year and into 2021. We are particularly excited about the multiple registrational or potentially registration-enabling studies currently underway that involve MacroGenics' own molecules or those we have partnered with. First, we await the near-term PDUFA decision by the U.S. FDA regarding marzituximab in late-line HER2-positive metastatic breast cancer. Next, we announced earlier this year our ongoing registrational trial of flotatuzumab in the treatment of primary induction failure refractory AML. Third, Prevention Bio recently completed the rolling submission of their BLA for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals. You'll recall that we had earlier developed and submitted salt supposumad to them in 2018.

Next we announced earlier this year, our ongoing Registrational trial of holiday and she is a man and the treatment of primary production failure refresh create them though.

Third prevention bio recently completed the rolling submission there be like for it to play the math, but the delay or prevention of clinical type one diabetes in the at risk individuals.

You'll recall that we had earlier developed and sold to please them back to them in 2018 if.

If approved we would receive a $60 million a milestone as well as royalties on sales.

Finally insight as multiple ongoing potentially registration, enabling studies for Red a family matter, which we licensed to them in 2017.

We are advancing our other than.

Internal and partnered programs with a goal of evaluating additional patients across multiple indications in order to potentially to find the next set of Registrational study.

I'd like to use this time to walk you through the updates on our portfolio of eight clinical molecules.

Scott Koenig: If approved, we would receive a $60 million milestone, as well as royalties on sale. Finally, Insight has multiple ongoing potentially registration-enabling studies for retifanilamab, which we licensed to them in 2017. We are advancing our other internal and partnered programs with a goal of evaluating additional patients across multiple indications in order to potentially define the next set of registrational studies. I'd like to use this time to walk you through the updates on our portfolio of eight clinical molecules. I will start with Flodituzumab, an investigational biospecific CD123 by CD3-DART molecule and our most recent product candidate to enter a registration study. During the third quarter, two manuscripts were published in Blood and Blood Advances, both publications of the American Society of Hematologists.

I will start with talking to them out and investigational by specific CB 123 by Cdthree Dart molecule.

And our most recent product candidate to enter a registration study.

During the third quarter, two manuscripts were published in blood and bloody advances both publications of the American Society of Hematology.

The first reported on clinical result, as of November 2019, well. The most recent one reported on the role of closer to the man in the immuno therapy of GBP 53 positive acute myeloid leukemia.

In addition, we are very excited that a six fold into the math and you know abstracts, including two Orals and four posters were accepted for presentation at the upcoming Ash annual meeting.

My understanding is that these abstracts will be released by yes Tomorrow morning.

We look forward to presenting additional data on this molecule next month.

Scott Koenig: The first reported on clinical results as of November 2019, while the most recent one reported on the role of flotatuzumab in the immunotherapy of TP53 positive acute myeloid leukemia. In addition, we are very excited that six phototuzumab and AML abstracts, including two orals and four posters, were accepted for presentation at the upcoming ASH annual meeting. My understanding is that these abstracts will be released by ASH tomorrow

How quickly remind listeners the macrogenics continues to enroll a single arm Registrational clinical study to evaluate some other Susan in up to 200 and no patients with primary induction failure or early relapse and mill with complete remission.

And see our was partial Lima logical recovery as the primary endpoint.

Oh, that's the Scots MGC away team, our investigational antibody drug conjugates designed to deliver a DNA isolating do upromise inside of toxic payload to cells that express piece of an age three.

Scott Koenig: We look forward to presenting additional data on this molecule next month. I'll quickly remind listeners that MacroGenics continues to enroll a single-arm registrational clinical study to evaluate slow-to-do demand in up to 200 AML patients with primary induction failure or early relapse AML, with complete remission and CR with partial hematological recovery as the primary endpoint. I'll next discuss MGC018, our investigational antibody drug conjugate designed to deliver a DNA acylating duochromosin cytotoxic payload to cells that express B7H3. Post-ASCO, we selected 3 mg per kg as the recommended dose for expansion. We recently commenced the enrollment of patients with metastatic castration-resistant prostate cancer, triple negative breast cancer, and non-small cell lung cancer in the dose expansion portion of the Phase I clinical study. The rationale for selecting metastatic castration-resistant prostate cancer patients is based on promising activity in dose escalation, which we previously presented at ASCO. Moreover, through our own IHC analysis of over 1,500 tumor tissue samples to date, we know that many solid tumors express B7H3, with several tumor types at an exuberant level.

Hosts ask though we selected three milligrams per kilogram as the recommended dose for expansion.

We recently commenced the enrollment of patients with metastatic castration resistant prostate cancer triple.

Triple negative breast cancer, and non small cell lung cancer and the dose expansion portion of the phase one clinical study.

The rationale for selecting metastatic castration resistant prostate cancer patients is based on promising activity in dose escalation, which we previously presented at ASCO.

Moreover, through our own I see analysis of over 1500 tumor tissue samples today, we know that many solid tumors express piece of an age three with several tumor types that exuberant levels.

We selected triple negative breast cancer as a second dose expansion cohort based on his piece of an agency expression, coupled with unmet medical need.

Finally, we selected non small cell lung cancer, not only due to its hard to break a b seven athree expression, but also because of the results previously reported and as our GC 28 gene regarding the activity of a no hutus a math I'll be 73 monoclonal antibody in combination with it.

An anti PD one in the non small cell lung cancer setting.

We are focused on execution of the MGC, Oh, 18 study and expect to provide an update on it next year.

Next I would like to turn to.

Telematics, our investigational by specific PD, one by last three Dart molecule previously known as Mgd of 13.

Scott Koenig: We selected triple negative breast cancer as a second dose expansion cohort based on its B7H3 expression coupled with unmet medical needs. Finally, we selected non-small cell lung cancer not only due to its high degree of B7H3 expression but also because of the results previously reported at SITC 2018 regarding the activity of inoblituzumab, our B7H3 monoclonal antibody, in combination with an anti-PD-1 in a non We are focused on the execution of the MGC 018 study and expect to provide an update on it next year. Next, I would like to turn to Tevotelumab, our investigational bispecific PD-1 bilat-3 DART molecule, previously known as MgDO13. Recall that we previously reported that lag-3 expression on immune effector cells was enhanced by margituximab, our investigational Fc-engineered monoclonal antibody targeting HER2.

Recall that we previously reported the last three expression on immune effector cells was enhanced by margin talk to map, our investigational FC engineered monoclonal antibody targeting her too.

Given the early efficacy signal an acceptable safety profile observed an initial small expansion cohort of patients.

We are evaluating the combination of tebow telematics and Martha talks emad in three subgroups of patients with her two positive tumors.

One would gastric and gastroesophageal junction cancer, another with breast cancer.

Well as a basket of other her two positive cancer types with 30 patients initially targeted for each group.

We believe that combining FC engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments.

We plan to present, a poster on the on going phase one dose expansion study a terrible tell them.

In combination with margin talks about in a cohort of patients with advanced her two positive tumors at the.

Scott Koenig: Given the early efficacy signal and acceptable safety profile observed in an initial small expansion cohort of patients, we are evaluating the combination of tebotelomab and margituximab in three subgroups of patients with HER2 positive tumors, one with gastric or gastroesophageal junction cancer, another with breast cancer, as well as a basket of other HER2 positive cancer types with 30 patients initially targeted for each We believe that combining FC engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments.

Coming society for immunotherapy of cancer annual meeting.

I believe that abstracts will be officially released by yes, RTC next week.

In addition, we will have a poster presentation at Ash next month regarding Tebow Telematics, India, We see hill.

Also based on early association of Biomarkers with clinical responsiveness to tell them that.

That we first first reported at ASCO. We are completing an assessment of biomarkers that can be used to screen and select patients who would have a greater likelihood to respond to treatment, including patients with DLP CEO and solid tumors.

We look forward to providing these updates.

Speaking of tableau tell them that I'd like to tell you about the study combining this molecule with another of our FC engineered antibody.

Scott Koenig: We plan to present a poster on the ongoing phase one dose expansion study of tebotelomab in combination with margituximab in a cohort of patients with advanced HER2 positive tumors at the upcoming Society for Immunotherapy of Cancer annual meeting. I believe that abstracts will be officially released by SITC next week. In addition, based on early association of biomarkers with clinical responsiveness to Tebotelumab that we first reported at ASCO, we are completing an assessment of biomarkers that can be used to screen and select patients who would have a greater likelihood to respond to treatment, including patients with DLBCL and solid tumors. We look forward to providing these updates.

In the first quarter 2021, we are planning to initiate a combination study of a novel to summit, which targets piece of an age three in a chemo free regimen in front line squamous cell carcinoma of the head in there with either tebow tell them out for patients who are PDL one negative.

Well with Renaissance in patients who are PDL one positive.

Blockade of the PDL, one PD, one inhibitory axis with rather family man is ideally suited for tumors with an underlying inflammatory response as indicated by the positive PDL one score at baseline.

In contrast, PDL, one negative tumors or those tumors lacking a T cell lymphoma trade may benefit from an FC engineered antibody like in the old Susan.

No to the man has been shown to induce an inflammatory T cell response in tumors in the Neoadjuvant clinical study of patients with newly diagnosed prostate cancer.

It has also been shown to enhance expression of checkpoint molecules, including both PDL, one and lag three and therefore patients may benefit by the contaminant treatment with tebow tell them through.

Scott Koenig: Speaking of tabotelumab, I'd like to tell you about a study combining this molecule with another of our FCNG-ridden antibodies. In the first quarter of 2021, we are planning to initiate a combination study of anoblatuzumab, which targets B7H3, in a chemo-free regimen in frontline squamous cell carcinoma of the head and neck, with either tebote Blockade of the PD-L1, PD-1 inhibitory axis with retifanilamide is ideally suited for tumors with an underlying inflammatory response, as indicated by the positive PD-L1 score at baseline. In contrast, PD-L1 negative tumors, or those tumors lacking a T-cell infiltrate, may benefit from an FC-engineered antibody like enolatuzumab Novotuzumab has been shown to induce an inflammatory T-cell response in tumors in a neoadjuvant clinical study of patients with newly diagnosed prostate cancer.

Through the calmer Torino blockade of the PD, one and lag three axes.

Moving on to margin talks about the.

The PDUFA target action date for our Bill way in metastatic Hertwo positive breast cancer is December 18th 2020.

In early October we had our late cycle meeting with the U.S.F.D.A.

Based on the current accrual rate of the overall survival events in the phase three Sophia study Macrogenics now anticipates accrual of the 380 says Oh, yes event, which triggers the final west analysis to take place in the second half of 2021.

FDIC has stated that they intend to meet their can do for date obligation on the basis of the Sofia studies primary PFS endpoint.

With a PDUFA date right around the corner, we are planning for the commercialization of Marjah toxin that if it is approved.

As we have previously discussed we do not currently intend to develop an internal sales force.

Scott Koenig: It has also been shown to enhance the expression of checkpoint molecules, including both PD-L1 and LAG-3, and therefore, patients may benefit from the concomitant treatment with tebotelimab through the combinatorial blockade of the PD-L1 and LAG-3 axes. Moving on to margituximab, the PDUFA target action date for our BLA in metastatic HER2 positive breast In early October, we had our late-cycle meeting with the USFDA.

Instead, we are evaluating a number arrangements with third parties, including providers of sales marketing distribution and logistics services as well as potential biopharmaceutical commercial partners, who may assist us with the potential launch of margin talks in that.

Beyond breast cancer. The phase two three mahogany study is evaluating margin talks to NAV and checkpoint blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer.

Module away the single on part of the mahogany study of margin talk to map and read a family man and investigational anti PD. One antibody is enrolling and we expect to submit data on a subset of the initially targeted 40 patients for presentation at a scientific conference in the first half of two.

Scott Koenig: Based on the current accrual rate of the overall survival events in the Phase 3 SOFIA study, MacroGenics now anticipates accrual of the 385th OS event, which triggers the final OS analysis to take place in the second half of 2021. FDAS stated that they intend to meet their PDUFA date obligation on the basis of the SOFIA study's primary PFS endpoint. With the PDUPA date right around the corner, we are planning for the commercialization of margituximab if it is approved. However, as we have previously discussed, we do not currently intend to develop an internal sales force.

The 21.

Macrogenics partner in greater China Xylem.

Recently announced dosing of the first patient in that region for module will be the randomized component. The mahogany that we'll evaluate margin talks about plus chemotherapy versus margin talks about plus chemotherapy.

Plus either read a family.

Or tivo tell them first.

First the standard of care, which is tries to them that plus chemotherapy.

Scott Koenig: Instead, we are evaluating a number of arrangements with third parties, including providers of sales, marketing, distribution, and logistics services, as well as potential biopharmaceutical commercial partners who may assist us with the potential launch of margituximab. Beyond breast cancer, the Phase 2-3 mahogany study is evaluating margituximab and checkpoint blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer Module A, the single-arm part of the mahogany study of margituximab and retifanilamab, an investigational anti-PD-1 antibody, is enrolling, and we expect to submit data on a subset of the initially targeted 40 patients for presentation at a scientific conference in the first half of 2021. MacroGenics partner in Greater China, Xylab, recently announced dosing of the first patient in Let me next discuss MGD-019, our investigational biospecific checkpoint dart molecule that targets PD-1 and CTLA-4. At the ESMO Virtual Congress in September, data from our Phase I Dose Escalation Study of MgD-019 were reported via oral presentation. MGD-019 was well tolerated in patients who received less than 10 mg per kilogram.

Let me now discuss mgd own 19.

Our investigational by specific checkpoint dart molecule that targets PD, one and CTO lay for.

At the ESMO virtual Congress in September data from our phase one dose escalation study of MDD own 19 was reported via oral presentation.

Mgo 19 was well tolerated in patients who received less than 10 megs per kilogram.

Of note dose dependent up regulation of the inducible co stimulator or Ipos molecule was evident in treated patients, including those who responded to mgo 19th therapy.

As well as T cell expansion.

And based on activity that was reported we are expanding the study initially in patients with microsatellite stable colorectal cancer and check point I'd non small cell lung cancer at the recommended phase two dose of six milligrams per kilogram.

Let me next turn to read some of them have previously known as Mgo, 12, and I and C. and G.A.O. one to the investigational anti PD, one antibody that we license to insight.

Macrogenics in inside have each established multiple development programs for this molecule.

Valuated, either as monotherapy or in combination with other agents.

Inside is conducting clinical trials that are potentially registration, enabling for patients with metastatic non small small cell lung cancer.

Squamous cell carcinoma of the idle can now mm.

Scott Koenig: Of note, dose-dependent upregulation of the inducible co-stimulator, or ICOS, molecule was evident in treated patients, including those who responded to MGD-019 therapy, as well as T-cell expansion. Based on the activity that was reported, we are expanding the study initially in patients with microsatellite-stable colorectal cancer and checkpoint IV non-small cell lung cancer at the recommended phase two dose of six mill Let me next turn to retifanilamab, previously known as MGA-012 and INC-MGA-0012, the investigational anti-PD-1 antibody that we licensed to Insight. MacroGenics and Insight have each established multiple development programs for this molecule, evaluating it either as monotherapy or in combination with other agents. Insight is conducting clinical trials that are potentially registration-enabling for patients with metastatic non-small cell lung cancer, squamous cell carcinoma of the anal canal, MSI high endometrial cancer, and Merkel cell carcinoma, while MacroGenics is conducting the potentially registration-enabling study in HER2 positive gastric cancer, as I mentioned previously.

MSR, hi, endometrial cancer, and Merkel cell carcinoma, while macrogenics is conducting the potentially registration enabling study in her two positive gastric cancer as I mentioned previously.

At the ESMO virtual Congress in September data from insights Merkel cell carcinoma.

And anal cancer monotherapy studies were presented.

Initial safety and activity data appear to be comparable to that of approved anti PD one monoclonal antibodies.

During the third quarter inside initiated the phase three podium threeo for clinical trial, which.

Which is evaluating the efficacy and safety of retina fathom.

With platinum based chemotherapy in patients with metastatic squamous and non squamous non small cell lung cancer.

This triggered a $15 million milestone payment to macrogenics.

We expect insight to initiate podium three all three in patients with anal cancer in the coming months.

In October we entered into a commercial supply agreement with insight as contemplated by our collaboration and license agreement.

Pursuant to which we are entitled to manufacture a portion of the global commercial supply needs for Renaissance man.

We plan to manufacture commercial rental found them and our five by 2000 liter scale GMP facility in Rockville, Maryland.

Scott Koenig: At the ESMO Virtual Congress in September, data from InSight's Merkel cell carcinoma and anal cancer monotherapy studies were presented. Initial safety and activity data appear to be comparable to that of approved anti-PD-1 monoclonal antibodies. During the third quarter, Insight initiated the Phase 3 Podium 304 clinical trial, which is evaluating the efficacy and safety of retifatlomab with platinum-based chemotherapy in patients with metastatic squamous and non-squamous non-small cell lung cancer. This triggered a $15 million milestone payment to MacroGenics.

I will remind listeners that under our collaboration agreement with Incyte, we are eligible to receive up to a total of $390 million potential remaining development and regulatory milestones in up to $330 million in potential commercial milestones.

Read of time, AMAP is approved and commercialized macrogenics would be eligible to receive royalties tiered from 15% to 24% on future worldwide net sales of the molecule.

And finally, we expect our second anybody drug conjugate I, MGC 936, and Abbvie targeting out of nine that is being advance under a co development agreement with immunogen to enter clinical testing in the near term.

Scott Koenig: We expect Insight to initiate podium 303 in patients with anal cancer in the coming months. In October, we entered into a commercial supply agreement with Insight, as contemplated by our Collaboration and License Agreement, pursuant to which we are entitled to manufacture a portion of the global commercial supply needs for Retifamlimab. We plan to manufacture commercial retifanilamab at our 5 by 2000 liter scale GMP facility in Rock

Under our 50 50 collaboration Immunogens, leading clinical development and they are currently screening patients for the phase one dose escalation study in patients with select advanced solid tumors.

As we hope you can see we continue to build momentum and advance our pipeline of innovative product candidates.

We would now be happy to open the call for questions operator.

Operator, before you or release the talk here for questions I'd like to add that the seven abstracts accepted for ash or prematurely release today and as such we released a press release earlier today.

Scott Koenig: I will remind listeners that under our collaboration agreement with Insight, we are eligible to receive up to a total of $390 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlamab is approved and commercialized, MacroGenics would be eligible to receive royalties tiered from 15 to 24 percent on future worldwide net sales of the molecule. And finally, we expect our second antibody drug conjugate, IMGC-936, and ADC targeting ADAM9, that is being advanced under a co-development agreement with Immunogen to enter clinical testing in the near term. Under our 50-50 collaboration, Immunogen is leading clinical development, and they are currently screening patients for the Phase I Dose Escalation Study in patients with select advanced solid tumors. As we hope you can see, we continue to build momentum and advance our pipeline of innovative product candidates. We would now be happy to open the call to questions. Operator.

Noting the titles in times of the presentation at Ash.

Operator, let's open the call to questions.

Thank you.

Ladies and gentlemen, as a reminder to ask the question you want to Express Star then one on your telephone.

Withdraw your question press the pound key.

Again that star one to ask the question.

Please stand by while we compile the culinary roster.

Our first question comes from the line of view children with Citigroup. Your line is open.

Great. Thank you very much for taking the questions congrats on the progress.

It was interesting and comparing that to the mab.

So sorry ash abstract that was just for me personally that the 2019.

Ash slides.

It looks like the incremental response rate was quite quite good seven out of 10 I just wondered if there was anything specific or different about those patients.

The led to the 70% incremental response rate.

Compared with the initial nine out of 28 sponsoring that we've seen in the <unk> and the 2019 data.

Operator: Operator, before you release the talk here for questions, I'd like to add that the seven abstracts accepted for ASH were prematurely released today. And as such, we released a press release earlier today, noting the titles and times of the presentations at ASH. With that, Operator, let's open the call for questions. Thank you. Ladies and gentlemen, as a reminder to ask a question, you may press star then 1 on your telephone. To withdraw your question, press the pound key.

Thanks for the question. So you know the presentation.

Last ash was approximately 30 to 30 patients.

What happened is that we are treated.

Very large group of patients subsequent to the ash meeting and the only patients that were.

Presented in the 38 that were in the abstract where those that were limited to a few lines of therapy as we have outlined with the FDA in our plans for our registration study. So we have eliminated some the patient or a significant number of those patients that we presented.

Yigal Dov Nochomovitz: Again, that's star number one to ask the question. Please stand by while we compile the Q&A roster. Our first question comes from the line of you, Nochomovitz, with Citigroup. Your line is open. Great, thank you very much for taking the questions. Congratulations on the progress. It was interesting to compare the flotatuzumab ASCO, sorry, ASH abstract that was just released versus the 2019 ASH slides. It looks like the incremental response rate was quite good, seven out of 10. I just wondered if there was anything specific or different about those patients that led to the 70% incremental response rate compared with the initial nine out of 28 response rate that we've seen in the 2019 data. Thanks, Yigal, for the question. So, you know, the presentation at the last ASH was approximately 30 patients.

Last year, so more than half the patients that you're going to see at the upcoming ash meeting our newly treated patients.

That had been enrolled in the study on there's a little more restrictive criteria.

But you are absolutely right we are seeing.

Improved response rates.

Even compared to the data from last year.

Okay great.

And then I was just wondering on MTV own a one nine.

You've announced plans for the expansion cohorts in MSS CRC in non small cell lung cancer, but you did have a complete response as I understand it in the in the metastatic castrate resistant prostate cancer patients.

Any particular reason youve chosen not to do an expansion cohort in.

See RPC.

Excellent question.

Obviously, we're very excited about the activity of this molecule.

Yigal Dov Nochomovitz: What happened is that we treated a very large group of patients subsequent to the ASH meeting, and the only patients that were presented in the 38 that were in the abstract were those that were limited to a few lines of therapy, as we have outlined with the FDA in our plans for our registration study. So we have eliminated some of the patients or a significant number of those patients that we presented last year. So more than half the patients that you're going to see at the upcoming ASH meeting are newly treated patients that have been enrolled in this study under a slightly more restricted criteria. But you are absolutely right.

We had to make some decisions in terms of priority and given the the.

The need for treating patients with.

And a stable colorectal cancer.

And seeing both patients that objective responses as well as tumors that shrunk we thought it would be worthwhile to expand that study to see how profound that signal was in colorectal cancer.

Well for a look at the non small cell lung cancer clearly there's been a lot of work on if he nivo combinations and we therefore want to establish how NGL 19 was performing compared to the large database that's already available for if he nivo, but we are not we have not lost sight of the.

Thank you.

Scott Koenig: We are seeing improved response rates, even compared to the data from last year. Okay, great. And then I was just wondering about MGD-019, you know, you've announced plans for the expansion cohorts in MSS-CRC and non-small cell lung cancer, but you did have a complete response, as I understand it, in a metastatic clostride-resistant prostate cancer patient. Any particular reason you chose not to do an expansion cohort in MCRPC? Excellent question!

Using MTO 19 in.

In castration resistant prostate cancer as you recall.

There has been activity that's been tested for MB nivo combinations in that indication.

Meanwhile, Bristol did not succeed in that trial, there was some activity in that combination.

Given that we also have explored the use of a novelist choosing to have a rather be 73 molecule Tom.

Targeting.

Hello.

Sorry.

Prostate cancer.

When they in collaboration with.

The group at Johns Hopkins in an iced tea and when we saw as patients.

Patients with single agent activity and as we are considering moving forward with NGL Nike, possibly even in combination with a novel twos in that but right now that's on the drawing board and nothing has been definitely decided yet.

Scott Koenig: Obviously, we're very excited about the activity of this molecule. We had to make some decisions in terms of priority, and given the need for treating patients with MS stable colorectal cancer and seeing both patients that had objective responses as well as tumors that shrunk, we thought it would be worthwhile to expand that study to see how profound that signal was in colorectal cancer. For our look at non-small cell lung cancer, clearly, there has been a lot of work on ipinevo combinations, and we therefore want to establish how MGD-019 is performing compared to the large database that's already available for ipinevo. However, we have not lost sight of the value of using MGD-019 in castration-resistant prostate cancer.

Thank you.

Our next question comes from the line of Evan Seigerman with credit Suisse.

Your line is open.

Thank you think suffer hey, Scott. Thank you so much for taking my question really congrats on the progress. This year. So I know you had met your started to alluding to some plans for commercializing Margetuximab you.

You had mentioned either kind of doing it I don't see in house, what kind of getting a contract sales.

Sales organization or partnering it out will you do you want to see the data from mahogany module, a before you make that decision and I'm just trying to get a sense as to when we could potentially start to see commercial sales or merger talks about in any other thoughts around how you would position the asset.

Evan Sigelman: As you recall, there has been activity that's been tested for ipinevo combinations in that indication, and while Bristol did not succeed in that trial, there was some activity in that combination. Given that, we also have explored the use of inoblituzumab or another B7H3 molecule targeting prostate cancer in collaboration with the group at Johns Hopkins in an IST, and what we saw as patients with single agent activity in this, we are considering moving forward with MGD-019, possibly even in combination with inoblituzumab, but right now, that's on the drawing board, and nothing has been definitively decided Thank you. Our next question comes from the line of Evan Sigelman with Credit Suisse. Your line is open.

In.

In the breast cancer space. Thank you.

Yes.

So much for your comments and your question.

So we as you point out as we stated today, we are exploring different avenues to commercialization both looking at potential contracting relation so that we have drug available if the FDA approves that by the PDUFA date.

In the early part of next year.

This is Adam we are also in discussions with.

Certain.

Companies.

Who might also served.

To commercialize this drug for us in the U.S.

We expect.

Operator: Thank you. Thanks, Operator. Hey Scott.

That again, if it's approved by the end of the year, we should be in a position to be in making an announcement.

Scott Koenig: Thank you so much for taking my question. Really, congratulations on the progress this year. So I know you started aluding to some plans for commercializing Margituximab. You had mentioned either kind of doing it, I don't want to say in-house, but kind of getting a contract sales organization or partnering it out.

Our plans for commercialization.

Sometime around December or early next year.

With regard to the decision around module a.

That is totally independent.

Clearly the opportunity to expand into a gastric setting in the front line would be great. But the data is still has to mature we still enrolling in that part of the study with regard to positioning this asset for other breast cancer.

Evan Sigelman: Will you, do you want to see the data from mahogany module A before you make that decision? I'm just trying to get a sense as to when we could potentially start to see commercial sales of margituximab and any other thoughts around how you would position the asset in the, you know, the breast cancer space? Thank you.

Indications.

There is an iced tea that has been initiated.

In patients.

With newly diagnosed breast cancer test.

Testing it.

Compared to standard of care.

The neoadjuvant setting as we pointed out.

The activity were seeing in late line her two positive tumors in combination with Tivo, which include breast cancer patients, we're continuing to expand that cohort and hopefully that may if successful providing the revenue to further develop margin tucks in that.

Scott Koenig: So we, as you point out and as we stated today, we are exploring different avenues for commercialization, both looking at potential contracting relationships so that we'd have the drug available if the FDA approves it by the PDUFA date in the early part of next year. And we're also in discussions with certain companies who might also serve to commercialize this drug for us in the U.S. We expect that, again, if it's approved by the end of the year, we should be in a position to be making an announcement about our plans for commercialization sometime around December or early next year. With regard to the decision on Module A, that is totally independent.

In a chemo free regimen. So we're very excited about the prospects, obviously and wait to hear from the FDA by the PDUFA date.

And just one follow up on EM.

I'm GCA zero when it's I know, we had some really interesting data at ASCO and you plan to provide a data update in the first half of 2021, I guess any thoughts as to what tumor types you want to pursue this or is this more of a tumor agnostic setting.

For a potential pivotal trial, assuming that the phase one data update on this positive next year.

Evan Sigelman: Clearly, the opportunity to expand into a gastric setting on the front line would be great, but the data still has to mature. We're still enrolling patients in that part of the study. With regard to positioning this asset for other breast cancer indications, there is an IST that has been initiated in patients with newly diagnosed breast cancer, testing it compared to standard of care in a neoadjuvant setting. And as we pointed out, the activity we're seeing in late-line HER2-positive tumors in combination with TIBA, which includes breast cancer patients, we're continuing to expand that cohort. And hopefully, that may, if successful, provide an avenue to further develop margituximab in a chemo-free regimen. So we're very excited about the prospects, obviously, and wait to hear from the FDA by PIDUFA day. And just one follow-up on MGC018. So I know we had some really interesting data at ASCO, and you plan to provide a data update in the first half of 2021. I guess you have any thoughts as to what tumor types you want to pursue this in?

Well on the or did you see Oh wait chain as Weve previously announced.

Karen right now.

Screening patients now for expansion in the metastatic castration resistant prostate cancer patients with hoping to enroll up to 40 patients to confirm the signal and extend that we've also announced that we are enrolling two small smaller cohorts one and two.

Negative breast cancer and one in non small cell lung cancer and those two will.

Well begin screening patients very shortly with that so those are the three initial indications we are pursuing but that doesn't eliminate it just to those three as you know we have shown quite nicely that.

73 is highly over expressed in both common and solid tumors and if in fact, we are.

I do think successful Dana these indications we clearly we'll look at additional indications both as monotherapy, but of course also in combination with other drugs and that and there's opportunities.

To expand that.

Soon.

In combination therapy as we.

I have got a lot of positive feedback of interest to us.

A look at different or sagna ways of addressing tumor control.

Excellent. Thanks, so much Scott for the color on both of those questions I'm sure we'll speak soon.

Thanks.

Thank you.

Scott Koenig: Or is this more of a tumor-agnostic setting, you know, for a potential pivotal trial, assuming that the phase one data update is positive next year? Well, on NGC 018, as we've previously announced, we're right now screening patients now for expansion in metastatic castration-resistant prostate cancer patients. We're hoping to enroll up to 40 patients to confirm the signal and extend it. We've also announced that we're enrolling two smaller cohorts, one in triple negative breast cancer, and one in non-small cell lung cancer, and those two will begin screening patients very shortly with that. So, those are the three initial indications we are pursuing, but that doesn't limit it just to those three. As you know, we have shown quite nicely that B7H3 is highly overexpressed in both common and solitude.

Our next question comes from the line of Tom Shrader with the T. I'd. Your line is open.

Hi, This is Kerry for Tom Thanks for taking our questions as far to model. The mahogany study evaluating combination with PD, one and PD <unk> PD one lag three can you tell us how do they fit into the treatment landscape.

Well you know again.

We're excited about this as you as you noted as we've noted.

That enrollment has just started through our partners on lab and we will.

Plans to begin enrolling in that portion of the study next year.

The goal there was obviously to build on the FC optimization technology, where as we have noted.

Activation of both the name specific immunity is achieved through that's the optimization. The question then becomes in patients that are for instance, PDL, one positive and may be sufficient to treat patients only with an anti PD one to get the enhanced therapeutic benefit but.

Evan Sigelman: And if, in fact, we are producing successful data in these indications, we clearly will look at additional indications, both as monotherapy but, of course, also in combination with other drugs. And there are opportunities to expand that soon in combination therapy, as we have gotten a lot of positive feedback of interest to look at different orthogonal ways of addressing tumor control. Excellent. Thanks so much, Scott, for the color on both of those questions. I'm sure we'll speak soon.

In those patients who have PDL one negative.

What we had previously observed that FC optimization can also enhance other checkpoint molecules like last three so using a molecule like tebow tell them that the PD one lag three by specific in combination could give a further.

Improvements of responses and so that was the rationale to design their molecule going forward, having said that I would I would put my bets on probably the combo with tebow tell them.

Operator: Thank you. Our next question comes from the line of Tom Schrader with BTIG. Your line is open. Hi, this is Kaveri for Tom.

But you know we don't have the data yet we'll have to see as it comes along.

That's helpful and do you expect to screen patients for luxury level based on the emerging data.

Kaveri Pohlman: Thanks for taking our question. For Module B of the Mahogany study, you're evaluating combinations with both PD-1 and PD-1 Lag-3. Can you tell us how they fit into the treatment landscape?

So that's that's an excellent question with regard to module B, there's no plans to screen those patients clearly we had the opportunity to retrospectively analyzed.

Scott Koenig: Well, you know, again, we're excited about this. As you noted, as we've noted, enrollment has just started through our partner, Xi Lab, and we will plan to begin enrolling in that portion of the study next year. The goal there was obviously to build on the FC optimization technology, where, as we have noted, activation of both innate and specific immunity is achieved through that FC optimization. The question then becomes, in patients that are, for instance, PD-L1 positive, it may be sufficient to treat patients only with an anti-PD-1 to get the enhanced therapeutic benefit.

In the context of the gastric study what we are doing.

And again wait for the presentation at ESI T C. On the combination of March and Tivo in the late her two positive populations.

As well as the data we've already presented with regard to the association of lag three expression and responsiveness in our monotherapy cohorts.

We are planning by the end of the year or early next year to be in a position to give a little bit more.

Disclosure on our plans for biomarker screening at this point, we think lag three expression either through our H.C.C. or through a transcript levels could be one very valuable biomarker, but there may be others that we might add to this as part of a screening for.

Scott Koenig: But in those patients who are PD-L1 negative, what we had previously observed is that FC optimization can also enhance other checkpoint molecules like LAG-3. So using a molecule like tebotelumab, the PD-L1-LAG-3 bispecific in combination, could give a further improvement in responses. And so that was the rationale to design that molecule going forward.

A seizure for enriching for populations that should respond hopefully would respond to tableau telematics.

That makes sense and it doesn't go work combining PD, one CPR rates will make sense before starting a large cohort.

So the PD ones can you.

Amplify wants what specific comp.

Indications are you talking about.

Scott Koenig: Having said that, I would put my bets on probably the combo with tebotelumab, but, you know, we don't have the data yet. We'll have to see as it comes along. That's useful. And do you expect to screen patients for lag-3 levels based on the emerging data? So that's an excellent question. With regard to Module B, there are no plans to screen those patients.

Hello.

Operator can you please.

He is out of the queue if she can press.

Press Star one.

Second and give me a little more details what you're looking for there and I'd be happy to answer there.

Thank you. Our next question comes from the line of Jonathan Miller with Evercore.

Hey, guys. Thanks, so much for taking my question.

Congrats on all the progress one thing I know it seems like there was a meaningful raised through the ATM facility, but you didn't give an update to guidance. So with that amount of cash that you are getting contemplated in your previous guidance or are you spending against it and if so what are you adding that that's.

Kaveri Pohlman: Clearly, we had the opportunity to retrospectively analyze this in the context of the gastric study. What we are doing, and again, we wait for the presentation at SITC on the combination of March and TiVo in late HER2-positive populations, as well as the data we've already presented with regard to the association of LAG-3 expression and responsiveness in our monotherapy cohorts, we are planning by the end of the year or early next year to be in a position to give a little bit more disclosure on our plans for biomarker screening. And at this point, we think LAG-3 expression, either through IHC or through transcript levels, could be one very valuable biomarker, but there may be others that we might add to this as part of a screening procedure for enriching for populations that should respond or, hopefully, would respond to tabotelumab. Does a cohort combining PD-1 and CTLA-4 make sense before starting a large cohort? So, Peter, what's your, can you amplify what specific indications are you talking about? Hello,

If you added a bunch of stuff, but what are you, adding that's new that you weren't thinking about before.

Secondly, I.

I wanted to ask about the.

PD, one lag three plus merge combo expansion in gastric that you're adding to that phase one that you discussed in the 100 L. One three section of your talk is that phase one expansion cohort potentially going to be available prior to mahogany part b data and if so does that inform your plans for.

Sure.

Virtue plus the bi specific condos in the.

In the controlled trial.

And then thirdly I just wanted to congratulate you on using the word exuberance to describe.

Expression levels.

A piece of an industry and welcome to business.

Well, thank you very much John.

That's correct.

Including the use of the word exuberant.

Let me go.

I'll go back to the second question and then I, you or Jim can comment on the ATM.

Operator: Operator, can you bring it back? Operator, can you bring it back? Please, out of the queue. If she can, press star 1 again.

With regard to the PD one lag three in combination with March in late line patients. So these are progressed most likely on her to another therapies.

Operator: Yeah, you'll have to come back and give me a little more details about what you're looking for there, and I'll be happy to answer you. Thank you. Our next question comes from Jonathan Miller with Evercore. Hey guys, thanks so much for taking my questions and congratulations on all the progress. One thing I noticed is that it seems like there was a meaningful raise for the ATM facility, but you didn't give an update on guidance. So was that amount of cash that you were getting contemplated in your previous guidance, or are you spending against it? And if so, what are you adding that's new that you weren't thinking about before? Obviously, you added a bunch of stuff. But what are you adding that's new that you weren't thinking about before?

We're not waiting for that expansion cohort, which we have.

You know characterize to enroll up to 30 patients. There. We obviously had several patients as these sort of our earlier presentation that responded to that but given that we're looking at module being a frontline setting we see that as two independent.

Pathways and clearly with the budget will be as you know already chemotherapy. There here, we're looking in the late line setting in the absence of chemotherapy. So.

Completely different plans with regard.

To use the time to tell them that they.

With regard to the ATM.

Just to comment on that was.

This is obviously gives opportunities to extend our runway.

It's a 2023.

Jonathan Miller: Secondly, I wanted to ask about the PD-1 LAG-3 plus MARGE combo expansion in gastric that you're adding to that Phase I that you discussed in the 013 section of your talk. Is that Phase I expansion cohort potentially going to be available prior to mahogany Part B data? And if so, does that inform your plans for HER2 plus the bispecific combos in the controlled trial? And then, thirdly, I just wanted to congratulate you on using the word exuberance to describe the expression levels of B7H3 and multiple sclerosis. Well, thank you very much, John, for those comments, including the use of the word exuberant.

The use of proceeds that have not been assigned to any particular program, but Jim you want to make a constitutional common.

Real quickly Jonathan.

The the ATM, obviously extended our runway a bit further into 2023 at this point, we're not providing the granularity.

With regard to.

Actually how far along it takes us.

Recall that we do stand to to potentially receive up to I guess, what remains 390 million of milestones from insight.

Well as Scott mentioned, the $60 million from prevention bio related to.

The delay should it be approved from.

From the <unk> to plus map.

Program.

And so all that together.

The runway does take us a little bit further but at this point, we're not really going to be precise about how far in 23 in Texas.

Scott Koenig: Let me go, I'll go back to the second question, and then Jim or I can comment on the ATM. With regard to PD-1 Lag-3 in combination with MARGE in late-line patients, so these have progressed most likely on HER2 and other therapies, we are not waiting for that expansion cohort, which we have characterized to enroll up to 30 patients there. We obviously had several patients, as you saw in our earlier presentation, that responded to that, but given that we're looking at Module B in a front-line setting, we see this as independent pathways, and clearly with Module B, as you know, we're adding chemotherapy there. Here we're looking in the late-line setting in the absence of chemotherapy, so two completely different plans with regard to the use of telomeres in that. With regard to the ATM, just to comment on that, it obviously gives opportunities to extend our runway into 2023, but the use of proceeds of that have not been assigned to any particular program, but Jim, you want to make additional comments? Yeah, real quickly, Jonathan, the ATM obviously extended our runway a bit further into 2023.

Okay that makes sense. Thanks, a lot I guess the one follow up I have then is in discussing.

Your CPR naive and non small cell cohort for a for a one nine.

I assume given that you want to directly compare or at least do cross trial comparison to the it'd be nivo combos that you're primarily interested in first line.

But can you comment on exactly what sorts of patients you're going to get and if the possibility exists for you to get later line of therapy patients who are still somehow checkpoint naive into that expansion cohort and how would you think about making that comparison, then I guess.

Yeah. That's a good question, John and obviously, we haven't started rolling that.

Clearly we are.

Planning to initiate.

Most of the recruitment of this outside the U.S. where.

It'd be nivo combinations have not been approved in.

The front line setting so.

Again, it's possible that we may include.

Post first line patients.

That had been naive to.

To anti PD, one or or or.

MP, but.

The majority, who we hope will be frontline patients.

James Karrels: At this point, we're not providing the granularity with regard to, you know, exactly how far along it takes us. Overall, we do stand to potentially receive up to, I guess, what remains, 390 million in milestones from Insight, as well as Scott mentioned, the $60 million from Prevention Bio related to the BLA, should it be approved from the Teplizumab program. And so all that together, you know, the runway does take us out a little bit further, but at this point, we're not really going to be precise about how far into 23. Okay, that makes sense. Thanks a lot.

Great. Thank you very much.

Okay. Thank you.

Well now go back to the line of Colombia.

Okay.

Hi, Thank you again for Tom just Rephrasing. My last question here are there any hint in the literature or that.

You have uncovered after the potential different places to use PD, one luxury versus PD, one CTL four.

Oh, Okay. So now that I understand thank you very much for that question you know clearly where we are starting to sort that out.

That mechanistically.

We may be talking about different T cell populations that may be address as you know.

The activation of T cells or inhibition induced through CTL four occurs in different compartments than say for instance, lag three remember as we've described.

Jonathan Miller: I guess the one follow-up I have then is in discussing your CPI-naive NSL, the non-small-cell cohort for 019. I assume, given that you want to directly compare, or at least do a cross-trial comparison to the ipinevo combos, that you're primarily interested in first-line, but can you comment on exactly what sorts of patients you're going to get, and if the possibility exists for you to get later line-of-therapy patients who are still somehow checkpoint-naive into that expansion cohort, and how would you think about making Yeah, that's a good question, John.

The design of these molecules a war for varying reasons in particular for the PD. One CTO laid for this was designed to try to markedly reduce the.

Toxicity profile that was observed at higher doses of people to deliver that and by.

Hitting using a bi specific dart molecule, we seem to be getting to.

Targeting primarily to the co expressing cells a PD one city like for that are found in the tumor micro environment as well as some that are PD. One positive alone. So this in fact is a great value for the use of this in different tumor settings.

Scott Koenig: And obviously, we haven't started rolling that out yet. Clearly, we're planning to initiate most of the recruitment of this outside the U.S., where IPI-nevo combinations have not been approved in the front-line setting. So, again, it's possible that we may include post-first-line patients that have been nave to anti-PD-1 or IPI, but the majority, we hope, will be front-line patients. Great, thank you very much. Thank you. We will now go back to the line of Kaveri.

With regard to the PD one lag three it's still too early right now to see to define what specific indication, but given our original.

Data that we demonstrated we seem to be having responses.

Particularly in tumors like triple negative.

Breast cancer, some ovarian cancer lung cancer, obviously, we're going to provide an update on deal Bcl. So clearly there's not there may be distinct populations and tumor types that are more preferable to be used with one versus the other.

Kaveri Pohlman: Your line is open. Hi, this is Karei again for Tom. Just rephrasing my last question here. Are there any hints in the literature or that you have uncovered as to the potential different sites to use PD-1 Lag-3 versus PD-1 CTLA-4? Oh, okay. So now that I understand, thank you very much for that question. You know, we're starting to sort that out, that mechanistically, we may be talking about different T cell populations that may be addressed. As you know, the activation of T cells or inhibition induced through CTLA-4 occurs in different compartments than, say, for instance, LAG-3. Remember, as we've described, the design of these molecules was for varying reasons. In particular, for PE1-CTLA-4, this was designed to try to markedly reduce the toxicity profile that was observed at higher doses of ipilimumab. And by hitting, using a bispecific DART molecule, we seem to be targeting primarily the co-expressing cells of PE1-CTLA-4 that are found in the tumor microenvironment, as well as some that are PE1-positive alone.

That's helpful. Thank you and congrats on the progress thank.

Thank you.

Thank you.

Our next question comes from Milan, Stephen Willey with Stifel. Your line is open.

Yes, thanks for taking the question.

So just going back to choose not for a moment, it's got United maybe talked about this before but.

I guess Joe.

Just curious as to what proportion of the responding patients might be progressing to transplant and I guess given that this is now a registrational trial, how does that potentially complicate the interpretations.

Duration of response just for the purposes.

Potential accelerated approval.

So you know Steve it's still too early to know exactly what percentage are going to go to transplant given that most of these patients.

Our.

Typically not candidates for transplant, obviously, we have to understand do they have.

Hey.

Potential well matched donor that can participate obviously there are underlying clint.

Scott Koenig: So this, in fact, is great value for the use of this in different tumor settings. With regard to PE1-LAG-3, it's still too early right now to define which specific indication, but given our original data that we demonstrated, we seem to be having responses, particularly in tumors like triple negative breast cancer, some ovarian cancer, and lung cancer. Obviously, we're going to provide updates on DLBCL. So clearly, there may be distinct populations and tumor types that are more preferable to be used with one versus the other.

Clinical condition apart from the email their agent such well all factor into that but we're hoping that over 50% of these patients ultimately may become candidates for transplant go on to transplant.

And right now that seems to be.

The percentage right now that.

Well we are.

Close to achieving.

Okay and has there been any regulatory dialogue about just.

How that gets incorporated into the agency's consideration of duration of response, which they traditionally held to be kind of a fairly important metric for the purposes of accelerated approval.

Kaveri Pohlman: That's helpful, thank you, and congratulations on the project. Thank you. Our next question comes from the line of Stephen Willey with Stateful. Your line is open.

Yes, we had that discussion with them on how to monitor those patients and include them in terms of survival and duration of response.

Stephen Douglas Willey: Yeah, thanks for taking the question. So just going back to floor two, there's a map for a moment, and I think Scott, you and I maybe talked about this before, but, I guess, just curious as to, you know, what proportion of the responding patients might be progressing to transplant. And I guess, given that this is now a registrational trial, how does that potentially complicate the interpretation? Duration of response, just for the purposes of a potential accelerated, So, you know, Steve, it's still too early to know exactly what percentage are going to go to transplant, given that most of these patients are typically not candidates for transplant. Obviously, we have to understand, do they have a potential match donor that can participate?

We are.

An analysis, that's devoted to those patients go on to transplant.

It is actually part of our secondary endpoints of the study.

Understood got it and then.

Just a question on the on the Margo trial.

And I know this is an investigator sponsored study I know to what extent you can provide.

Context around the trial design, but.

Well, it's just kind of curious as to what's the.

What's the end game here right I mean, it's it's a.

It's obviously overpowered in terms of it being kind of a proof of concept trial, but you know, it's probably not sufficiency.

Should be large enough for any kind of regulatory considerations. So.

I guess, if you could just.

Maybe walk us through like the the rationale for having such a large kind of open label with an active comparator single site that many patients.

Scott Koenig: Obviously, their underlying clinical condition, apart from the AML, their age, and such will factor into this, but we're hoping that over 50% of these patients ultimately may become candidates for transplant and go on to transplant. And right now, that seems to be the percentage that we are close to achieving. Okay, and has there been any regulatory dialogue about just how that gets incorporated into the agency's consideration of duration of response, which they've traditionally held to be kind of a fairly important metric for the purposes of an accelerated approach? Yes, we had that discussion with them about how to monitor those patients and include them in terms of survival and duration of response. There will be an analysis that's devoted to those patients who go on to transplant. It is actually part of our secondary endpoints for the study. I understand. I got it. And then, Just a question on the Margo trial.

That would be helpful.

Are we talking about the Neoadjuvant study, you're talking about yeah, correct, yes, it's not a single site. There I think the we like 90 sites. This is a consortium.

So it's actually going to be conducted in probably some of the major breast cancer sites in the country.

The goal here is actually we're looking at the full wheel population.

And we are again trying to take advantage of the.

The salutary effect so the.

Engineering of the FC region here to get a better response, obviously it wasn't sized.

For a study for approval, but hopefully we will see trends there with regard to.

Benefit so you know that that's the intense at this point.

Okay.

Thank you.

Our next question comes from the line of Exar.

Guggenheim Securities Your line is open.

Great Congrats on the progress and thanks for taking my question. So first question for me maybe you can speak to the response Oh, one would expect in relapsed refractory AML patients with TPG Pfifty three mutations help maybe put the 60% response were seeing.

Scott Koenig: And I know this is investigator-sponsored, so I don't know to what extent you can provide some context around the trial design. But I was just kind of curious as to what's the endgame here, right? I mean, it's obviously overpowered in terms of it being kind of a proof of concept trial, but you know, it's probably not sufficiently sufficiently large enough for, you know, any kind of regulatory consideration. So, I guess if you could just maybe walk us through the rationale for having such a large kind of open label with an active comparator, single site, that many patients, that would be helpful. Are we talking about the new Agilent study you're talking about? Yeah, correct. Yeah, it's not a single site.

What that population Outfought Proto choosy about it to some sort of context.

Second question.

Yes, as you know this is probably one of the most difficult.

Mutated subsets in am now aware.

The expectation of responsiveness is less than 10%. So the fact that we were seeing such a high response rate in a subset.

Scott Koenig: There are, I think there'll be like 19 sites. This was a consortium. So it's actually going to be conducted probably at some of the major breast cancer sites in the country. The goal here is actually we're looking at the epithelial population, and we are again trying to take advantage of the salutary effects of the engineering of the FC region here to get a better response. Obviously, it wasn't sized for a study for approval, but hopefully, we will see trends there with regard to benefit. So that's the intent at this point.

We're.

Very excited about.

Initial date, obviously, we're going to expand this with additional patients and monitor this but.

You know the data speaks for itself.

Great. Thanks for that and then secondly for MGT over to be true. If you really can comment on this but you know we know in this complete response and deal Bcl on that was a CD not experience patient, but wondered if you could elaborate at all on the other three patients.

Scott Koenig: Thank you. Our next question comes from the line of Etzer Darout with Guggenheim Securities. Your line is open.

That had partial responses and whether or not those were also sort of.

Archie experience. Obviously this this is sort of from the abstracts are released today.

Etzer Darout: Great. Congratulations on the progress. And thanks for taking my question. So first question for me, maybe you can speak to the response that one would expect in relapsed refractory AML patients with TP53 mutations.

Yes, so as well.

Wait for the city, it's kind of very shortly.

In fact, we'll probably have even additional I mean this data at ash, that's coming up obviously in about a month.

Scott Koenig: Just to help maybe put the 60% response we're seeing with that population from Proto-Tuzolab into some sort of context, and then I have a second question. Yeah, as you know, this is probably one of the most difficult mutated subsets in AML, where the expectation of responsiveness is less than 10%. So the fact that we saw such a high response rate in this subset is very exciting. Obviously, we're going to expand this with additional patients and monitor this, but the data speaks for itself. Great, thanks for that. And then secondly, for MGD-013, not sure if you can really comment on this, but we know in this complete response in DLBCL, you know, that was a CD9-experienced patient, but wondered if you could elaborate at all on the other three patients that had partial responses and whether or not those were also sort of CAR T-experienced. Obviously, this is sort of from the abstracts released today. Yeah, so I wanted to wait for the CITSE.

You know the specifics around those patients will be described there and I think by that time, we should be able to include some additional valuable patients in that cohort.

In the abstract we're only at the cut off date had ones that had already had scan. So I think there's been a couple additional patients that will be included in that analysis, so well wait for that but we're happy we're very excited about the activity were seeing here and again well be looking at various biomarkers associated with responsiveness as well.

Thank you.

Our next question comes from the line of Jonathan Chang with SBB Leerink. Your line is open.

Hi, Tim This is John Barrett on for Jonathan a couple of questions on flow to today.

Regarding the the Registrational trial now running for that molecule what would be the overall benchmark to define the positive trial triple or twos ma'am.

And based on all the translational researchers presented are there any pre defined patient subgroups for.

This molecule, which you could seek approval if you do not meet the activity.

Threshold in the overall population.

And thanks for the question.

Scott Koenig: It's coming up very shortly. In fact, we'll probably have even more, I mean, this is at ASH. It's coming up, obviously, in about a month.

We are clearly not giving the definitive benchmarks, what we have guided in the past is that.

Patients that typically fail high dose chemotherapy in the front line setting.

Scott Koenig: You know, the specifics around those patients will be described there, and I think by that time, we should be able to include some additional valuable patients in that cohort. In the abstract, we were only at the cutoff date for those that had already had scans. So I think there's been a couple additional patients that will be included in that analysis. So we'll wait for that, but we're very excited about the activity we're seeing here.

On the first.

Salvage it's had we're talking about at best low double digit responsiveness and then on subsequent failures.

Salvage success goes down dramatically so low single digits is zero and so as a result, we had conducted an analysis of the literature over the last 30 years to define what we expect to beat the mean and median a response rate that population based.

Different treatment regimens and presented that analysis to the FDA the form the basis for the design of a Registrational study obviously for competitive reasons, we don't want to give you. This the specific details details there, but you can gather what range, we're talking about here and given the historical success, we've had with the small.

Scott Koenig: And again, we'll be looking at various biomarkers associated with responsiveness as well. Thank you. Our next question comes from the line of Jonathan Chang with SBB. Leverine, your line is open. Hi, team. This is John Barrett on for Jonathan.

So so far in these defined population with regard to the Biomarkers that you.

Two.

You know, we had toyed with the idea of.

Working on treat.

Predefine populations based on the Biomarkers, but this is still in an evolution phase right now we want to obviously expand this data we will do a retrospective analysis of the current patients in the current study, but the beauty of this is and you'll hear much more data on this at the Ashley.

Jonathan Chang: A couple of questions on flutatuzumab. Regarding the registrational trial now running for that molecule, what would be the overall benchmark to define a positive trial for flutatuzumab? And based on all the translational research you've presented, are there any predefined patient subgroups for this molecule for which you could seek approval if you do not meet the activity threshold in the overall population? John, thanks for the question. We are clearly not giving the definitive benchmarks.

Doing so.

Beyond that the the whole call. The P 53 population, which clearly we could go after there are other biomarkers that we can combine.

With the gamma interferon associated genes.

There were there were defining the response the population, but there will be a few just studying in a future design.

Got it and one more just regarding execution for that trial do you have any expectations on how long this trial could enroll or take to come to the end of the trial.

Scott Koenig: What we have guided in the past is that, you know, patients that typically fail high-dose chemotherapy in the frontline setting, on the first salvage attempt, we're talking about, at best, low double-digit responsiveness, and then on subsequent failures, salvage success goes down dramatically to low single-digit to zero. And so, as a result, we conducted an analysis of the literature over the last 30 years to define what we expected to be the mean and median response rate in that population, based on different treatment regimens, and presented that analysis to the FDA to form the basis for the design of our registrational study. Obviously, for competitive reasons, we don't want to give you the specific details there, but you can see what range we're talking about here and, given the historical success we've had with this molecule so far in these defined populations.

Yes, so again, we've been guiding that our aspiration is to enroll this by the end of next year, but given the whole COVID-19 situation.

We were hoping that there wouldn't be a flare in Europe as you've heard a number of countries again are shutting down their hospitals right now we're still on target on terms of our enrollment rates, but I can't predict what's going to happen over the next few months. So again. The hope is that we'll have this enroll by the end of next year.

Got it thank you.

Thank you.

Our next question comes from the line of Boris Peaker Cowen Your line is open.

Hey, this is to be on for Boris Thank you for taking our question.

I can talk to the Adam 980, C. and can you comment about what you are looking far regarding patient flood Chen are you playing to screen for lyles levels of Adam nine expression.

And finally based on the data you have so far are there particular tumor types that look attractive for that.

Escalation thanks.

Scott Koenig: With regard to the biomarkers that you've alluded to, we have toyed with the idea of working on predefined populations based on the biomarkers, but this is still in an evolution phase right now. We obviously want to expand this data. We will do a retrospective analysis of the current patients and the current studies, but the beauty of this is, and you'll hear much more data on this at the ASH meeting, so beyond the P53 population, which clearly we could go after, there are other biomarkers that we can combine with the gamma interferon-associated genes that were defining the response to this population, but that will be a future study and a future design. And one more just regarding execution for that trial.

Okay.

So thanks very much for the question of course, we're very excited with our partner Immunogen.

On the initiation of this trial.

I expect they will also provide some update on their conference call with regard to the study we had defined several different tumor types.

For a room in the dose escalation part of the study.

But did not define is based on Adam knowing levels over expression. Clearly this is something we can analyzer retrospectively and with regard to expansions that will obviously be dictated on both the responsiveness in safety, we see in the dose escalation phase.

Thank you.

Our next question comes from the line of Peter Lawson of Barclays. Your line is open.

Hey, Thanks, Scott Thanks for taking the questions.

Scott Koenig: Do you have any expectations about how long this trial could enroll or take to come to the end of the trial? Yeah, so again, we've been guiding that our aspiration is to enroll this by the end of next year. But given the whole COVID-19 situation, you know, we were hoping that there wouldn't be a flare in Europe.

Brett from the progress.

Just firstly just on the next update for the prostate data. So MGC when might you start in the first half or is that for the other indications triple negative breast cancer of lung that we see.

Thanks Peter.

Scott Koenig: As you've heard, a number of countries are again shutting down their hospitals. Right now, we're still on target in terms of our enrollment rates, but I can't predict what's going to happen over the next few months. So again, the hope is that we'll have this enrolled by the end of next year. Thank you. Thank you. Our next question comes from the line of Boris Peeker. Scott Koenig, your line is open. Hey, this is Cynthia Ahn for BORIS.

As I've mentioned on previous calls you know our goal was soon.

To enroll those as quickly as possible as I noted earlier, we're screening these patients now.

You know, we like to get as many of the 40 patients in the first half by the first half of next year. So.

Wayne is to try to provide an.

An update.

No later by midyear next year.

Perfect. Thank you and then if do you get a better sense of how it's working.

Well in prostate is is that something to do with the tumor microenvironment or what are your thoughts there.

Cynthia Ahn: Thank you for taking our questions. For the last, I guess, ADAM9 ADC, can you comment about what you and Immunodent are looking for regarding patient selection? Are you planning to screen for levels of ADAM9 expression? And finally, based on the data you have so far, are there particular tumor types that look attractive for the phase one dose escalation? Thanks.

No I.

I mentioned this before we don't think there's anything specific to prostate from the data that were presented in the phase. One study, we think that that was sort of a serendipitous that.

One of the first patients that seem to respond was that the two mics per gig level and as a result, the investigators decided that.

Many more of the prostate patients to that two or three makes for kids because they had nothing to treat these patients and sort as an opportunity I should note as I said before of the two patients with non small cell lung cancer, one or 0.5 and the other at.

Scott Koenig: So thanks very much for the question. And of course, we're very excited with our partner, Immunogen, on the initiation of this trial. I expect they will also provide some updates on their conference call with regard to this study. We had defined several different tumor types for enrollment in the dose escalation part of this study, but we did not define this based on ADAM9 levels or expression.

Two makes for Qig, both those patients had tumor reductions with a patient treated that to make strict kid had a 24% reduction of a very large lung there.

We don't see that specifically the microwave the macro environment at this point.

Scott Koenig: Clearly, this is something we can analyze retrospectively. And with regard to expansions, that will obviously be dictated by both the responsiveness and safety we see in the dose escalation phase. Thank you. Your next question comes from the line of Peter Lawson for Barclays. Your line is open.

As Dick telling but we are looking at.

Various immune markers and that could obviously contribute as well one of the things that you.

Remember, we made a comment that there seems to be immune activation as a result of using this particular apatow with the a b C and so if you remember in the original design of the Phase One study we have an arm that we have included.

Peter Richard Lawson: Thanks, Scott. Thanks for taking the questions.

Operator: Congratulations on the progress. Firstly, just on the next update for the prostate data, so MGC018, is that in the first half, or is that for the other indications, triple negative breast cancer, or lung that we've, Thanks, Peter. As I've mentioned on previous calls, you know, our goal was to enroll us as quickly as possible.

To add read a family Matt.

Two mg.

Oh 18, but given the exuberant sponsors we had seen.

With.

The.

The patients we put that combination study on how well we will clearly come back to doing some combinations with the Red Falcon one of our other checkpoint molecules.

Thanks, Thanks for the update around that.

Scott Koenig: As I noted earlier, we're screening these patients now. You know, we would like to get as many of the 40 patients in by the first half of next year. So our plan is to try to provide an update no later than mid-year next year. Perfect, thank you. And then, do you get a better sense of how it's working so well in prostate cancer? Is that something to do with the tumor microenvironment, or what are your thoughts, Peter? As I mentioned before, we don't think there's anything specific to prostate cancer from the data that we presented in the Phase I study. We think that it was sort of serendipitous that one of the first patients that seemed to respond was at the two mix per kick level, and as a result, the investigators decided to add many more of the prostate patients to that two and three mix per kick level because they had nothing to treat these patients with and saw it as an opportunity.

Adam knowing that the AIDC when could we see the initial data for that.

Well again when the study is just starting and it all be dictated by.

Obviously.

The ability to recruit patients, which I don't think we'll be difficult.

There will be several sites open.

That will be enrolling patients, but clearly we'll have to you know obviously monitor the safety as well. So it's just too early to give you any.

Advice about time great.

Great and then I seem to.

Pondering the merger talks about that's kind of on hold with the kind of the lumen commercialization.

That's not what I was saying I maybe I.

What I said was misinterpreted we are in discussions both.

Scott Koenig: I should note, as I said before, of the two patients with non-small cell lung cancer, one at 0.5 and the other at two mix per kick, both those patients had tumor reductions, with the patient treated at two mix per kick having a 24% reduction in a very large lung mass. We don't see that specifically the microenvironment at this point as dictating, but we are looking at various immune markers, and that could obviously contribute as well.

Looking at various vendors that can help us get the drug available to patients.

To use it obviously there are a lot of steps on bringing a drug drug to market, but we're also working with groups that can fully commercialized.

Including.

Typical biopharmaceutical companies so.

As I noted earlier in this call.

If we have an approval by the PDUFA date, we should be in a position around that time or soon thereafter.

To discuss the issue.

Commercialization of that molecule. So nothing is really on hold we're actually actively discussing prospects with various partners.

Scott Koenig: One of the things that you should remember, we've made a comment that there seems to be immune activation as a result of using this particular epitope with the ADC. And so if you remember in the original design of the Phase I study, we had an arm that we included to add retifamilumab to MGC018. But given the exuberant responses we had seen with the prostate patients, we put that combination study on hold, but we will clearly come back to doing some combinations with either retifamilumab or one of our other checkpoint molecules. Thanks for the update around that. Adam9, the ADC, when can we see the initial data for that?

Great. Okay. Thank you so much thanks for taking the questions.

Thank you as a reminder, ladies and gentlemen that star one if youd like to ask the question.

Our next question comes from the line of you Gal.

From Citigroup your.

Your line is open.

Thank you so much for taking the follow up just two one on much tougher having one on other people that.

Obviously, you mentioned that the due date of December.

Team.

He made no mention of an AD com is that is that the interpretation that there is no longer interested in an advisory committee meeting for.

Peter Richard Lawson: Well, again, the study is just starting, and it'll all be dictated by, obviously, the ability to recruit patients, which I don't think will be difficult. There'll be several sites open that will be enrolling patients, but clearly, we'll have to, you know, obviously monitor the safety as well. So it's just too early to give you any advice about timing.

Martin talked snap.

Then secondly.

The the goalpost seem to shift a bit with respect to the the timing of the three or 30, 385th overall survival of and originally it was.

The end of this year and now it's the second half of next year I'm. Just wondering if there's anything to me native that in terms of a read through and.

Scott Koenig: Great. And then I assume for partnering, a major tax amount that's kind of on hold with the kind of looming commercialization. But that's not what I was saying.

Arms of the greater overall survival benefit.

And then on to the map just operationally could you just explain the comment in the abstract with respect to.

Peter Richard Lawson: Maybe what I said was misinterpreted. We are in discussions, both looking at various vendors that can help us get the drug available to patients who need it. Obviously, there are a lot of steps to bring a drug to market, but we're also working with groups that can fully commercialize it, including typical biopharmaceutical companies. So, as I noted earlier in this call, if we get approval by the PDUFA date, we should be in a position around that time or soon thereafter to discuss the commercialization of that molecule. So, nothing is on hold. We're actually actively discussing prospects with various partners.

The outpatient dosing given though the trending down of of the Crs events.

And in the <unk> during the first cycle, how how is it possible to do the out patient dosing.

Context of a 28 day continuous infusion for the for the first cycle. Thank you.

Thank you God sort of follow up so we had announced earlier this year that the FDA had told us that Tom was not necessary and there's been no change in that.

And again.

The interaction with the FDA has been very positive clearly.

Scott Koenig: Great. Okay. Thank you so much. Thanks for taking the question. Thank you. As a reminder, ladies and gentlemen, that's Star 1 if you'd like to ask a question. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open.

Clearly they make the final decision but.

You know we're on track for them to meet their PDUFA requirement. So no outcome there with regard to the 385th event.

I think you picked up on an important point.

Which is.

The death of overall are slowing down and given.

That again, we saw some.

Yigal Dov Nochomovitz: Thank you so much for taking the follow-up. Just two on margituximab and one on flotatuzumab. Obviously, you mentioned the PDUFA date of December 18th, but you made no mention of an ADCOM.

Numerical.

Inc.

Reduction in the debts for patients treated with March versus TRASM.

Scott Koenig: Is that the interpretation that the FDA is no longer interested in an advisory committee meeting for Margituximab? And then, secondly, the goalposts seem to shift a bit with respect to the timing of the 385th overall survival event. Originally, it was the end of this year, and now it's the second half of next year.

Clearly, we hope that that trend continues.

And.

We see that potentially that's very favorable that these patients are living longer so.

Again, all a positive from an hour.

Interpretation, so far the data with regard to offload the tusa and out patient dosing.

Scott Koenig: I'm just wondering if there's anything to be made of that in terms of a read-through in terms of the greater overall survival benefit. And then on flotatuzumab, just operationally, could you just explain the comment in the abstract with respect to outpatient dosing, given the trending down of the CRS events during the first cycle? How is it possible to do outpatient dosing in the context of a 28-day continuous infusion for the first cycle?

Member.

What we have said is that the initial eight days.

Treatment occurs in patients because the patients have been tolerating the.

The drug.

The there is a leading dosing during that first week and as we've noted before it.

It is at that timeframe, we will it will be the greatest time, where you would see any cytokine release that needed to be addressed although as we pointed out we have dramatically reduced.

Yigal Dov Nochomovitz: Thanks, Yigal, for the follow-up. So we had announced earlier this year that the FDA had told us that an ATCOM was not necessary, and there's been no change in that. And again, the interaction with the FDA has been very positive. Clearly, they make the final decision, but we're on track for them to meet their PDUFA requirements, so no ATCOM there.

Risks there associated with Crs So as a result these patients can.

Have a pump.

I would say take with them.

Potentially home, which then they would.

Scott Koenig: With regard to the 385th event, I think you've picked up on an important point, which is that deaths overall are slowing down. And given that, again, we saw some numerical reduction in the deaths for patients treated with MARJ versus TRAS, clearly, we hope that that trend continues, and we see that, potentially, that's very favorable that these patients are living longer. So, again, all positive from our interpretation so far of the data. With regard to flotatuzumab and outpatient dosing, remember what we have said is that the initial eight days of treatment occur inpatients because the patients have been tolerating the drug. There is a lead-in dosing during that first week, and as we've noted before, it is at that timeframe that you would see any cytokine release that needed to be addressed. Although, as we pointed out, we have dramatically reduced the risk there associated with CRS. As a result, these patients can have a pump and a pack, which they take with them, potentially home, which then they would replace every several days with a new infusion. This is not any different than what is used in flotatuzumab.

Replaced every several days with a a new a new infusion.

This is not any different than is used in blinatumomab.

Okay got it thank you so much.

Thank you.

I'm showing no further questions in the queue.

I would now like to turn the call back over to Dr. stop Kenny for closing remarks.

Thank you operator, and thanks, everybody for participating in our call today, and we look forward to speak to you about updates.

You should call have a nice evening.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

[music].

Mm.

[music].

Yigal Dov Nochomovitz: Oh, okay. Got it. Thank you so much. Thank you. I'm showing no further questions in the queue.

Operator: I would now like to turn the call back over to Dr. Scott Koenig for closing remarks. Thank you, operator. And thanks, everybody, for participating in our call today. And we look forward to speaking to you about updates at a future call. Have a nice evening. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.